Warring Drug Companies Put Profit Above Patients, Claims Author

Oct. 14--Drug companies Johnson & Johnson and Amgen battled
each other so bitterly in a market share war that they pushed drugs
and dosages jeopardizing patients' lives, said the Santa Barbara
author of a book about Johnson & Johnson whistle-blowers.

Kathleen Sharp's "Blood Feud" focuses on anemia drugs created by
Amgen when the Thousand Oaks biotech giant was just a startup.
Procrit, sold by Johnson & Johnson through what Sharp describes
as a conflict-riddled partnership with Amgen, and Amgen's own
Epogen and Aranesp all became popular, billion-dollar drugs.

The Food and Drug Administration in June said the drugs can
cause fatal health problems for chronic kidney disease patients,
including strokes and heart issues. Agency officials advised that
doctors talk to their patients about the risks and that the drugs
be administered in the lowest dose possible. Four years earlier,
FDA warnings included evidence suggesting higher doses of the drugs
to patients with head and neck cancers could increase the
progression of the diseases.

Amgen and Johnson & Johnson knew for many years about
studies suggesting health risks related to the medications, Sharp
said. But she said the companies pushed higher dosages of the drugs
as early as the mid-1990s and constantly tried to invade each
other's territory to gain more of the market, with Amgen reaching
out to cancer patients and Johnson & Johnson aiming for people
in dialysis.

"Bitter, bitter war," Sharp said Wednesday before a presentation
at Chaucer's Books in Santa Barbara. "It's kind of like an
unmitigated corporate greed to push a product for no human
need."

Amgen officials declined to comment on many of Sharp's
allegations, saying that part of her book focuses on litigation
between whistle-blowers and Ortho Biotech, a subsidiary of Johnson
& Johnson that sold Procrit and is now known as Janssen
Biotech. The lawsuit doesn't involve Amgen, said company
spokeswoman Mary Klem.

Epogen and similar drugs created by Amgen are breakthrough
biotechnology medications that help patients avoid blood
transfusions, Klem said. She acknowledged there are safety
considerations.

"Amgen's mission is to serve patients, and we have always been
committed to the safe use and responsible marketing of our
products," she said. "Everyone at Amgen is held to the highest
ethical standard for doing the right thing for patients."

Mark Wolfe, a spokesman for Johnson & Johnson, said Sharp
misrepresented data about the value of its drug Procrit.

"Our most immediate concern is that patients facing serious
illnesses could be unnecessarily alarmed by Ms. Sharp's
allegations, distortions and inaccuracies," he said.

Sharp defended her book and said that neither Johnson &
Johnson nor Amgen agreed to repeated requests for interviews. An
investigative journalist, she has written for the The New York
Times and Boston Globe and authored three previous books. Mark
Duxbury, a Johnson & Johnson division salesman turned
whistle-blower, started contacting her seven years ago. He told her
of how sales teams were being pushed to defraud Medicare and sell
Procrit at dosages and for uses that endangered patients.

She said the book is based on hundreds of interviews and
thousands of documents -- from Duxbury, a second whistle-blower,
the FDA, congressional hearings and litigation involving Amgen,
Ortho Biotech and others.

Her book begins with a cancer patient on Procrit who bled to
death. She also explores whistle-blower allegations that Ortho
overbilled Medicare and paid kickbacks to doctors who prescribed
Procrit.

Although her book focuses on Johnson & Johnson and its
subsidiary, Ortho, Sharp said a similar whistle-blower case is
being litigated against Amgen.

Klem said Amgen will vigorously defend itself against the
allegations.

The litigation against Ortho has followed a roller-coaster ride
that included a dismissal by a federal judge in 2008 and a
reinstatement the next year. A hearing is set for December,
although one of the whistle-blowers and a protagonist in Sharp's
book died in October 2009.

Sharp said the hearing, along with the Amgen whistle-blower
litigation, means more attention will be focused on the profit
competition driving pharmaceutical giants.

She wants drug companies and doctors to provide transparent
information to patients about medication risks. But she also wants
people to take as much responsibility as they can by doing research
and asking point-blank questions.

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